Table 1.

Main clinical trials evaluating use of patiromer for chronic hyperkalemia.

Study, Year	Study Population	N	Study Design (with Patiromer Dosage)	Follow-Up (Weeks)	Main Results
PEARL-HF 2012 [55]	CHF, CKD or previous hyperkalemia causing RAASi interruption plus indication to start spironolactone	105	Randomized and double blind: patiromer 15 g bid vs. placebo Spironolactone starting dose 25 mg, progressive dose titration	4	Mean K+ reduction: −0.45 mmol/L patiromer vs. placebo (P < 0.001)
AMETHYST-DN 2015 [56]	Diabetes plus CKD (stage 3–4) receiving RAASi with known hyperkalemia or those who developed hyperkalemia during run-in phase	306	Randomized and open label. Patients on ACEi or ARB started on spironolactone (1)Mild HK (5.1–5.5 mmol/L): Patiromer 4.2–8.4–12.6 g bid (2)Moderate HK (5.6–5.9 mmol/L): Patiromer 8.4 g– 12.6 g–16.8 g bid	52	(1)Mild HK: K+ reduction − 0.35 mmol/L for 4.2 g, −0.51 mmol/L for 8.4 g, −0.55 mmol/L for 12.6 g (2)Moderate HK: K+ reduction −0.87 mmol/L for 8.4 g −0.97 mmol/L for 12.6 g −0.92 for 16.8 g
OPAL-HK 2015 [57]	CKD patients (stage 3–4) on RAASi	243	Initial treatment phase: (1)Mild HK (K+ 5.1–5.5 mmol/L) Patiromer 4.2 g bid (2)Moderate HK (K+ 5.6 –5.9 mmol/L) Patiromer 8.4 g bid	4	Mean K+ reduction: −1.01 mmol/L vs. basal values
		107	Randomized maintenance phase: Continue patiromer (n = 55) vs. placebo (n = 52)	8	K+ increase: +0.72 mmol/L in placebo vs. 0 mmol/L in patiromer (P < 0.001)

Abbreviations: CHF, Chronic heart failure; CKD, Chronic Kidney Disease; HK, Hyperkalemia; RAASi, Renin-Angiotensin-Aldosterone system inhibitors; bid, twice a day.